Pasithea Therapeutics

What Pasithea Therapeutics does

Pasithea Therapeutics Corp. (NASDAQ: KTTA) is a clinical-stage biotechnology company incorporated in Delaware on May 12, 2020 and headquartered in Miami Beach, Florida. The company's mission, as stated in its corporate filings, is to discover, research and develop innovative treatments for CNS disorders and RASopathies, with its lead drug candidate PAS-004 being a next-generation macrocyclic mitogen-activated protein kinase (MEK) inhibitor positioned as a differentiated successor to approved MEK inhibitors selumetinib and mirdametinib.

PAS-004 is currently advancing through two Phase 1 programs: a Phase 1 dose-escalation study in adults with MAPK pathway-driven advanced solid tumors at four U.S. and three Eastern European sites, and a Phase 1/1b trial in adult NF1 patients with symptomatic or inoperable plexiform neurofibromas at five sites in the U.S., Australia and South Korea. In 2026 the candidate received FDA Fast Track and Rare Pediatric Disease Designations for NF1 and Orphan Drug Designation for ALS, with a discovery-stage PAS-001 program also addressing schizophrenia. The pipeline was historically supplemented by acquired assets — AlloMek Therapeutics (CIP-137401) in October 2022 and Alpha-5 Integrin in June 2022 — and by the now-discontinued PAS-003 ALS program and Pasithea Clinics ketamine infusion services (dissolved September 2025).

Pasithea generates no product revenue and operates a pre-revenue model funded entirely by equity financings (cumulative ~$50.4M raised including a $60M December 2025 public offering led by Adage Capital, Janus Henderson, Vivo Capital, Columbia Threadneedle, Coastlands and Squadron Capital) plus grant income from FightMND and the ALS Association. The customer base, in lieu of commercial buyers, consists of clinical trial investigators and patients across five countries, with go-to-market oriented toward regulatory milestones, KOL engagement and institutional investor development through H.C. Wainwright as exclusive placement agent.

Name

Pasithea Therapeutics

Legal name

Pasithea Therapeutics Corp.

Website

https://pasithea.com

Company type

Public

Founded year

2020

Operating status

Operating

Headcount range

11–50 employees

Short description

Pasithea Therapeutics (NASDAQ: KTTA) is a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor for NF1-associated plexiform neurofibromas, MAPK pathway-driven advanced tumors, and ALS, with a discovery-stage schizophrenia program (PAS-001). The pre-revenue company is funded by equity financings and grants, targeting orphan-disease patients across multi-continent clinical trials.

Ownership category

akta.pro rank

Headquarters

HQ city

Miami Beach

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Others

Revenue model

1. No product revenue (pre-revenue clinical-stage): Pasithea is a clinical-stage biotechnology company with no approved products and no product revenue. Operations are funded through equity financings (IPOs, private placements, ATM offerings, public offerings) and grant income. The company has incurred recurring losses and negative operating cash flows since inception, with an accumulated deficit of approximately $72.9 million as of March 31, 2026. Grant income recorded as contra R&D expense (e.g., $43,000 in Q1 2025).

Go-to-market motion2 records

Distribution channels1 record

Marketing channels7 records

Core offering

Pasithea Therapeutics is a clinical-stage biotechnology company developing innovative treatments for CNS disorders and RASopathies. Its lead candidate PAS-004 is a next-generation macrocyclic MEK inhibitor in Phase 1/1b trials for NF1-associated plexiform neurofibromas and Phase 1 trials for advanced cancer with MAPK pathway mutations. The company has also received FDA Orphan Drug Designation for PAS-004 in ALS. Additional pipeline includes the discovery-stage PAS-001 program for schizophrenia. Pasithea has no approved products and no product revenue.

Product overview

Pasithea Therapeutics is a clinical-stage biotechnology company with a single-product-platform focused on the discovery, research and development of innovative treatments for RASopathies, MAPK pathway-driven tumors and CNS disorders. Its core offering centers on the lead drug candidate PAS-004, a next-generation macrocyclic MEK inhibitor advancing through Phase 1 trials in advanced cancer and Phase 1/1b trials in NF1-associated plexiform neurofibromas, supplemented by a discovery-stage schizophrenia program (PAS-001). The portfolio was historically augmented by acquired assets via the AlloMek Therapeutics (CIP-137401) and Alpha-5 Integrin, LLC acquisitions, and the discontinued PAS-003 ALS program and Pasithea Clinics ketamine infusion services have been wound down. Together these products represent Pasithea's pipeline spanning oncology, neurofibromatosis, ALS, and CNS disorders.

Differentiator

Problem solved

Functional benefit

Brands

• PAS-004: Next-generation macrocyclic MEK inhibitor, the company's lead drug candidate in clinical development for NF1-associated plexiform neurofibromas, advanced cancer, and ALS.
• PAS-001

Products and services

• PAS-004 Next-generation macrocyclic MEK (mitogen-activated protein kinase) inhibitor developed as a therapeutic candidate for neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas, MAPK pathway-driven advanced tumors, and ALS. Currently in Phase 1 trials for advanced cancer and Phase 1/1b trials for NF1. Has received FDA Fast Track, Rare Pediatric Disease, and Orphan Drug Designations.
• PAS-001

Segments5 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature4 records

Partnerships

Five partnerships are on record, tiered major, core and minor.

• Children's Tumor FoundationmajorGTM or Marketing Partner · 26 June 2026Pasithea exhibited at the Children's Tumor Foundation 2026 NF Conference (June 26-30, 2026, Denver, Colorado) following receipt of FDA Fast Track and Rare Pediatric Disease Designations for PAS-004. Engagement aimed at strengthening collaboration with the NF1 clinical and academic community to advance better-tolerated NF1 therapies.
• AlloMek Therapeutics, LLCcoreStrategic or Co-development Partner · 11 October 2022Pasithea acquired AlloMek Therapeutics on October 11, 2022. Deal included upfront cash, shares, warrants, milestone payments, and royalties. Brought in CIP-137401, a macrocyclic MEK inhibitor candidate targeting CNS indications including neurofibromatosis type 1 and Noonan syndrome, with planned IND filing in second half of 2023. Now operated as a wholly owned subsidiary.
• Alpha-5 Integrin, LLCcoreStrategic or Co-development Partner · 22 June 2022Pasithea acquired Alpha-5 Integrin, LLC in a $3.75 million transaction. Acquisition included Alpha-5's proprietary monoclonal antibodies targeting alpha-5/beta-1 integrin, scientific team, and laboratory. The program supports ALS treatment development and triggered a AUD $1 million (~$694,000) research grant from FightMND. Now operated as a wholly owned subsidiary.
• University of Alabama at Birmingham (UAB Medicine)coreImplementation/ SI/ Consulting PartnerClinical trial site activated November 2025 for ongoing Phase 1/1b trial of PAS-004 in adult NF1 patients. Site led by Dr. Rebecca Brown (Associate Professor of Neuro-Oncology at UAB Medicine), a member of Pasithea's Scientific Advisory Board who has been investigator on dozens of NF1 studies. Site supports enrollment and conduct of NF1-plexiform neurofibroma clinical trial.
• Genentech (Dr. Krishnan's prior affiliation)minorOthersIndirect partnership through new CMO Kartik Krishnan, M.D., Ph.D. (effective May 1, 2026), who previously worked on cobimetinib (Cotellic), an FDA-approved MEK inhibitor at Genentech. The PAS-004 program benefits from this expertise on next-generation MEK inhibitors.

Scale indicators11 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Exelixis: Exelixis co-developed cobimetinib (Cotellic), the FDA-approved MEK inhibitor now central to Pasithea's CMO Kartik Krishnan's credibility. Comparable MEK-inhibitor expertise and oncology focus.
• BioMarin Pharmaceutical: BioMarin is a commercial-stage rare disease biotech with overlapping CNS and oncology pipeline adjacency; comparable patient populations in ultra-rare diseases and similar orphan-drug commercial strategy.
• AstraZeneca: Markets selumetinib (Koselugo) — the first FDA-approved MEK inhibitor for NF1-PN — and acquired SpringWorks in 2025, consolidating the NF1 MEK space. Direct incumbent competitor with deep commercial reach.

Direct peers

• SpringWorks Therapeutics: SpringWorks' lead asset mirdametinib (Gomekli) is an FDA-approved MEK inhibitor for NF1-associated plexiform neurofibromas — the most direct competitive comparator to PAS-004 in NF1-PN. Same mechanism (MEK inhibition), same patient population, same regulatory pathway.
• Day One Biopharmaceuticals: Day One's OJEMDA (tovorafenib) is FDA-approved for pediatric NF1-PN, directly competing in Pasithea's lead indication. Comparable stage (commercial-stage rare-disease oncology) and shared NF1 KOL ecosystem.
• MEI Pharma: Clinical-stage oncology biotech with MAPK-pathway-adjacent pipeline (ME-344, zandelisib). Similar size, similar development stage, similar MEK pathway mechanism.
• Kura Oncology: Clinical-stage precision oncology biotech with MAPK pathway-targeted candidates (tipifarnib, KO-539). Same MAPK pathway thesis and comparable development stage to Pasithea.

Emerging players

• Neumora Therapeutics: CNS-focused clinical-stage biotech with a pipeline spanning schizophrenia, ALS, and other neuropsychiatric indications; same therapeutic focus areas (CNS/Schizophrenia) as Pasithea's PAS-001 and ALS programs.
• Maplight Therapeutics: Clinical-stage CNS-focused biotech with schizophrenia pipeline; directly comparable to Pasithea's PAS-001 discovery-stage schizophrenia program targeting treatment-resistant populations.
• Syndax Pharmaceuticals: Clinical-stage oncology biotech with small-molecule pipeline targeting cancer biology; comparable scale and late-Phase 1/early-Phase 2 development stage, though different molecular targets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/PasitheaCorp
• Facebookfacebook.com/profile.php
• LinkedInlinkedin.com/company/75885048
• Instagraminstagram.com/pasitheacorp

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries5 records

Funding overview

Funding rounds7 records

Investors8 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A2 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Pasithea Therapeutics